A Randomized, Controlled, Investigator-Assessor Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Water-Soluble Head Lice Suffocation Product (X92001666) vs RID Shampoo (Pyrethrin) in Subjects With Head Lice

Oystershell NV2 sites in 1 country70 target enrollmentMarch 7, 2018

ConditionsHead Lice Pediculosis Capitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Head Lice
Sponsor: Oystershell NV
Enrollment: 70
Locations: 2
Primary Endpoint: Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).

Detailed Description

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo). The study will be performed in subjects ≥2 year of both genders with confirmed diagnosis of head lice infestation. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.

Registry

clinicaltrials.gov

Start Date

March 7, 2018

End Date

June 30, 2018

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oystershell NV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Gender: male / female.
•Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.
•Female subjects: are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
•or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation),
•or women who are ≥60 years of age.
•Age: ≥ 2 year of age at the time of enrollment.
•Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 apparently live nits, present on the scalp and/or hair, as determined by a trained evaluator.
•Subject is in good general health based on medical history.
•The subject or his/her parent/legal guardian must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study. A caregiver must sign an informed consent agreement for children not old enough to do so. Children ages 6-18 years of age will be administered a child's assent form. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
•Following application and rinsing of the test products, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post treatment evaluation has been completed.

Exclusion Criteria

•Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 30 days prior to their screening visit (Day 1).
•Application of any topical medication of any kind on the hair for a period of 48 hours prior to the screening visit.
•Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
•Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
•History of allergy or hypersensitivity to ragweed, active ingredients or constituents of the test products.
•Subject with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test product.
•Subjects with chronic scalp disorder.
•Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/or may be likely to exhibit poor compliance with the required visits.
•Females who are pregnant or nursing.
•Hair longer than mid-back.

Outcomes

Primary Outcomes

Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).

Time Frame: Day10

Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs

Secondary Outcomes

Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations).(Day 1)
Effect of Both Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day10)
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations).(Day 10)
Effect of Both Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day10)
Effect of Both Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day10)
Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations).(Day 1)
Effect of Both Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day10)
Global Tolerability, Evaluated at Study End (Visit 4, Day 10)(Day 10)
Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Including All Baseline Infestations).(Day 10)
Effect of Both Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day10)
Effect of Both Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day10)
Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations).(Day 10)